Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-0740

2. Registrant Information.

Registrant Reference Number: 2015KP368

Registrant Name (Full Legal Name no abbreviations): Bayer Inc

Address: 2920 matheson BLVD

City: Mississaugua

Prov / State: ON

Country: Canada

Postal Code: L4W 5R6

3. Select the appropriate subform(s) for the incident.

Domestic Animal

4. Date registrant was first informed of the incident.

15-JAN-16

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

16-NOV-15

Product Description

7. a) Provide the active ingredient and, if available, the registration number and product name (include all tank mixes). If the product is not registered provide a submission number.

Active(s)

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PMRA Registration No.       PMRA Submission No.       EPA Registration No. 11556-155

Product Name: Seresto Collar

• Active Ingredient(s)
  • Flumethrin
  • IMIDACLOPRID
    • Guarantee/concentration 10 %

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7. b) Type of formulation.

Other (specify)

collar

Application Information

8. Product was applied?

Yes

9. Application Rate.

1

Other Units: collar

10. Site pesticide was applied to (select all that apply).

Site: Animal / Usage sur un animal domestique

11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).

On approximately 10Nov2015, a 2 year old, 4 pound, intact,female, Domestic Longhair feline, in unknown condition with an abnormally low body weight, had 1 Seresto Cat(Flumethrin-Imidacloprid) collar placed around the neck by the owner.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Yes

Subform III: Domestic Animal Incident Report

1. Source of Report

Other

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Longhair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

2

7. Weight (provide a range if necessary )

4

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>1 wk <=1 mo / > 1 sem < = 1 mois

10. Time between exposure and onset of symptoms

>3 days <=1 wk / >3 jours <=1 sem

11. List all symptoms

System

• General
  • Symptom - Death
  • Symptom - Lethargy
  • Symptom - Weakness

• Respiratory System
  • Symptom - Dyspnea

• General
  • Symptom - Vocalizing
  • Symptom - Hypothermia
  • Symptom - Jaundice

• Blood
  • Symptom - Anemia

12. How long did the symptoms last?

>24 hrs <=3 days / >24 h <=3 jours

13. Was medical treatment provided? Provide details in question 17.

Yes

14. a) Was the animal hospitalized?

No

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Died

16. How was the animal exposed?

Treatment / Traitement

17. Provide any additional details about the incident

(eg. description of the frequency and severity of the symptoms

On 16Nov2015, the feline was admitted to the clinic, unspecified anesthetics were administered, and a routine ovariohysterectomy was performed. On 06Dec2015, the feline was examined by a veterinarian. She presented lethargic, dyspneic, weak, crying out, hypothermic, and icteric. Blood work was performed and revealed anemia. The collar was removed. The feline was treated with unspecified antibiotics and fluids by an unspecified route. On 07Dec 2015, the feline died.

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To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Death

19. Provide supplemental information here

Reported signs including icterus and anemia are not anticipated with appropriate product application. Even oral exposure to the collar is not expected to cause serious signs. An overdose of 5 collars around the neck was investigated in adult cats and dogs for an 8 months period and in 10 week old kittens and 7 week old puppies for a 6 months period without causing serious signs. No signs of anaphylaxis reported which would have occurred in close proximity to the collar application. Signs are likely related to other unknown conditions. Though its unknown if necropsy was performed, considering the known product profile and long time to onset, sufficient information exists to conclude that the product did not cause the event. Finally, product involvement considered to be unlikely.